Early-Life Socioeconomic Circumstances and Physical Activity in Older Age: Women Pay the Price.

Health in older age is shaped by early-life socioeconomic circumstances (SECs) and sex. However, whether and why these factors interact is unclear. We examined a cultural explanation of this interaction by distinguishing cultural and material aspects of SECs in the context of physical activity-a major determinant of health. We used data from 56,331 adults between 50 and 96 years old from the Survey of Health, Ageing and Retirement in Europe (SHARE), a 13-year, large-scale, population-based cohort. Confounder-adjusted logistic linear mixed-effects models showed an association between the cultural aspects of early-life SEC disadvantage and physical activity among women, but it was not consistently observed in men. Furthermore, these associations were compensated for only partially by adult-life socioeconomic trajectories. The material aspects of early-life SECs were not associated with adult-life physical activity. These findings highlight the need to distinguish different aspects of SECs because they may relate to health behaviors in diverse ways.

InterMob: a 24-month randomised controlled trial comparing the effectiveness of an intervention including behavioural change techniques and free transport versus an intervention including air pollution awareness-raising on car use reduction among regular car users living in Grenoble, France.

BACKGROUND: Frequent car use contributes to health and environmental issues such as air pollution, climate change and obesity. Active and sustainable mobility (bike, walk, public transport, car sharing) may address these issues. Different strategies have been implemented in past research, involving hard levers, aimed at modifying the economical or geographical context (e.g., free public transport), and soft levers, aimed at modifying psychological processes (e.g., personalised transport advice). However, few studies have combined both hard and soft levers. In addition, few have used robust methodologies (e.g., randomised controlled trials), followed behavioural changes in the long-term, and been anchored in behaviour change theories. InterMob aims to address these limits by implementing a 24-month randomised controlled trial including hard and soft levers. The objectives of InterMob are to a) evaluate the effectiveness of an experimental arm versus an active controlled arm, and b) identify the processes of mobility change. METHODS: Regular car users living in Grenoble (N = 300) will be recruited and randomised to one of the two arms. The experimental arm consists in a six-month intervention combining hard levers (free access to transport/bikes), and soft levers (e.g., personalised transport advice). The control arm consists in a six-month intervention aimed at raising awareness on air pollution and its health effects. Both arms will include eight evaluation weeks (spread out over 24 months) based on a GPS, an accelerometer, and a pollution sensor. Moreover, participants will complete mobility logbooks and surveys measuring psychological constructs, socio-economical, and socio-spatial characteristics. DISCUSSION: InterMob will assess the effectiveness of two interventions aimed at reducing car use within regular car users in the short-, mid- and long-term. Moreover, InterMob will allow to better understand the psychological processes of behaviour change, and the socio-economical and geographical conditions under which the intervention is efficient in reducing car use. Finally, the benefits of mobility change in terms of physical activity, quality of life, and exposure to pollution will be quantified. TRIAL REGISTRATION: ClinicalTrials.gov : NCT05096000 on 27/10/2021 (retrospectively registered).

Evaluating the Effectiveness of Gamification on Physical Activity: Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Gamification refers to the use of game elements in nongame contexts. The use of gamification to change behaviors and promote physical activity (PA) is a promising avenue for tackling the global physical inactivity pandemic and the current prevalence of chronic diseases. However, there is no evidence of the effectiveness of gamified interventions with the existence of mixed results in the literature. OBJECTIVE: The aim of this systematic review and meta-analysis is to evaluate the effectiveness of gamified interventions and their health care potential by testing the generalizability and sustainability of their influence on PA and sedentary behavior. METHODS: A total of 5 electronic databases (PubMed, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials) were searched for randomized controlled trials published in English from 2010 to 2020. Eligibility criteria were based on the components of the participants, interventions, comparators, and outcomes framework. Studies were included when they used gamified interventions in daily life with an active or inactive control group and when they assessed a PA or sedentary behavior outcome. We conducted meta-analyses using a random-effects model approach. Sensitivity analyses, influence analyses, and publication bias analyses were performed to examine the robustness of our results. RESULTS: The main meta-analysis performed on 16 studies and 2407 participants revealed a small to medium summary effect of gamified interventions on PA behavior (Hedges g=0.42, 95% CI 0.14-0.69). No statistical difference among different subgroups (adults vs adolescents and healthy participants vs adults with chronic diseases) and no interaction effects with moderators such as age, gender, or BMI were found, suggesting good generalizability of gamified interventions to different user populations. The effect was statistically significant when gamified interventions were compared with inactive control groups, such as waiting lists (Hedges g=0.58, 95% CI 0.08-1.07), and active control groups that included a nongamified PA intervention (Hedges g=0.23, 95% CI 0.05-0.41). This suggests that gamified interventions are not only efficient in changing behavior but also more effective compared with other behavioral interventions. The long-term effect (measured with follow-up averaging 14 weeks after the end of the intervention) was weaker, with a very small to small effect (Hedges g=0.15, 95% CI 0.07-0.23). CONCLUSIONS: This meta-analysis confirms that gamified interventions are promising for promoting PA in various populations. Additional analyses revealed that this effect persists after the follow-up period, suggesting that it is not just a novelty effect caused by the playful nature of gamification, and that gamified products appear effective compared with equivalent nongamified PA interventions. Future rigorous trials are required to confirm these findings.

Fear of failure in Brazilian runners.

This study aims to investigate the fear or failure (FoF) in Brazilian runners of both sex, performance levels and age categories, as well as to verify the relationship between FoF and socioeconomic status (SES). Sample size as composed by 916. Age, sex, body height, body weight, SES, and running pace were self-reported. The Multidimensional Questionnaire of FoF was applied in an online platform. Running pace, and SES were categorized and processed through multivariate analysis and Spearman correlations, with the p-value set at 0.05. Female runners with better performance (2.13 ± 0.74) and younger (2.16 ± 0.80), as a well as male runners with worse performance (2.04 ± 0.69) and older (2.04 ± 0.89) presented the highest values of FoF. Among women, SES was negatively associated with FoF (r = -0.144; p = 0.006), while a positive association between running pace and SES was observed among men (r = 0.290; p < 0.001). Non-professional Brazilian runners presented low values of FoF.

Why Are Individuals With Diabetes Less Active? The Mediating Role of Physical, Emotional, and Cognitive Factors.

BACKGROUND: Despite the key role of physical activity in the management of diabetes, many individuals with diabetes do not engage in the recommended levels of physical activity. However, our knowledge of the mechanisms underlying the relationship between diabetes and physical inactivity is limited. PURPOSE: To investigate the associations between diabetes and the levels and evolution of physical activity across aging, and to determine whether physical, emotional, and cognitive factors mediate these associations. METHODS: Data from 105,622 adults aged 50-96 years from the Survey of Health, Ageing and Retirement in Europe (SHARE) were used in adjusted linear mixed models to examine whether diabetes was associated with physical activity levels and variations across aging. The potential mediators were subjective energy, muscle strength, physical and cognitive disability, sleep problems, depressive symptoms, and cognitive functions. The variables were measured up to seven times over a 13-year period. RESULTS: Individuals with diabetes demonstrated a lower level and a steeper decrease in physical activity across aging than individual without diabetes. Mediators explained ~53% and 94% of the association of diabetes with the level of physical activity and with the linear evolution of physical activity across aging, respectively. All mediators were significantly associated with physical activity. Physical and cognitive disability as well as depressive symptoms were the strongest mediators, while sleep was the lowest one. CONCLUSIONS: These findings suggest that the etiology of physical inactivity in individuals with diabetes can result from several physical, emotional, and cognitive changes associated with the emergence of this disease.

Muscle strength explains the protective effect of physical activity against COVID-19 hospitalization among adults aged 50 years and older.

Physical activity has been proposed as a protective factor for COVID-19 hospitalisation. However, the mechanisms underlying this association are unclear. We examined the association between physical activity and COVID-19 hospitalisation and whether this relationship was explained by risk factors (chronic conditions, weak muscle strength). We used data from adults over 50 years from the Survey of Health, Ageing and Retirement in Europe. The outcome was self-reported hospitalisation due to COVID-19, before August 2020. The main exposure was physical activity, self-reported between 2004 and 2017. Among the 3139 participants included (69.3 ± 8.5 years, 1763 women), 266 were tested positive for COVID-19, 66 were hospitalised. Logistic regression models showed that individuals who engaged in physical activity more than once a week had lower odds of COVID-19 hospitalisation than individuals who hardly ever or never engaged in physical activity (odds ratios = 0.41, 95% confidence interval = 0.22-0.74, p = .004). This association between physical activity and COVID-19 hospitalisation was explained by muscle strength, but not by other risk factors. These findings suggest that, after 50 years, engaging in physical activity is associated with lower odds of COVID-19 hospitalisation. This protective effect of physical activity may be explained by muscle strength.

Relationships between changes in self-reported physical activity, sedentary behaviour and health during the coronavirus (COVID-19) pandemic in France and Switzerland.

To assess whether changes in physical activity and sedentary behaviour during the COVID-19 lockdown are associated with changes in mental and physical health. Observational longitudinal study. Participants living in France or Switzerland responded to online questionnaires measuring physical activity, physical and mental health, anxiety, and depressive symptoms. Paired sample t-tests were used to assess differences in physical activity and sedentary behaviour before and during lockdown. Multiple linear regressions were used to investigate associations between changes in physical activity and changes in mental and physical health during lockdown. 267 (wave1) and 110 participants (wave2; 2 weeks later) were recruited. Lockdown resulted in higher time spent in walking and moderate physical activity (~10min/day) and in sedentary behaviour (~75min/day), compared to pre COVID-19. Increased physical activity during leisure time from week 2 to week 4 of lockdown was associated with improved physical health (ß=.24, p=.002). Additionally, an increase in sedentary behaviour during leisure time was associated with poorer physical health (ß=-.35, p=.002), mental health (ß=-.25, p=.003), and subjective vitality (ß=-.30, p=.004). Ensuring sufficient levels of physical activity and reducing sedentary time can play a vital role in helping people to cope with a major stressful event, such as the COVID-19 pandemic.

Do compensatory health beliefs predict behavioural intention in a multiple health behaviour change context? Evidence in individuals with cardiovascular diseases?

Multiple health behaviour change (MHBC) represents one of the best ways to prevent reoccurrence of cardiovascular events. However, few individuals with cardiovascular diseases engage in this process. The present study examined the role of compensatory health beliefs (CHB; i.e., belief that a healthy behaviour compensates an unhealthy one) as a drag to engagement in this process. Some studies have shown that CHBs predict intention to engage in healthy behaviours, but no study has investigated CHBs in individuals who actually need to change multiple health behaviours. The goal was to better understand the role of CHBs in intentions formation process among individuals with cardiac diseases in an MHBC context. One hundred and four patients completed a questionnaire at the beginning of their cardiac rehabilitation program. Results showed that: (1) CHBs negatively predicted intentions (2) but only for participants with high self-efficacy or low risk perception; (3) CHBs predictions differed depending on the nature of the compensating behaviour, and were more predictive when medication intake was the compensating one. Findings only partially confirmed previous research conducted on healthy individuals who were not in an MHBC process, and emphasized the importance of considering CHBs for individuals in this process.

Cognitive resources moderate the adverse impact of poor perceived neighborhood conditions on self-reported physical activity of older adults.

Poor neighborhood conditions are associated with lower levels of physical activity for older adults but socio-ecological models posit that physical activity depends on both environmental and individual factors. Older adults' ability to overcome environmental barriers to physical activity may partially rely on cognitive resources. However, evidence on the moderating role of these cognitive resources in the associations between environmental barriers and physical activity is still lacking. We analyzed cross-national and longitudinal data on 28,393 adults aged 50 to 96 years as part of the SHARE. Lack of access to services and neighborhood nuisances were used as indicators of poor neighborhood conditions. Delayed recall and verbal fluency were used as indicators of cognitive resources. Confounder-adjusted generalized estimation equations were conducted to test associations between neighborhood conditions and self-reported moderate physical activity, as well as the moderating role of cognitive resources. Results showed that poor neighborhood conditions reduced the odds of engagement in physical activity. Cognitive resources robustly reduced the adverse influence of poor neighborhood conditions on physical activity. Participants with lower cognitive resource scores showed lower odds of engaging in physical activity when neighborhood conditions were poorer, whereas these conditions were not related to this engagement for participants with higher cognitive resource scores. These findings suggest that cognitive resources can temper the detrimental effect of poor neighborhood conditions on physical activity. Public policies should target both individual and environmental factors to tackle the current pandemic of physical inactivity more comprehensively.

If You Are Old and Do Not Want to Fall into The Traditional Stereotype--Be Physically Active!

UNLABELLED: BACKGROUND/STUDY CONTEXT: Based on the stereotype content model and the behaviors from intergroup affect and stereotypes map (Cuddy et al., 2008; Advances in experimental social psychology [Vol. 40, pp. 61-149], New York: Academic Press), we examined whether being physically active may challenge the traditional stereotypes related to older adults. METHODS: We compared how 94 participants (M(age) = 24.48 years, SD = 7.15 years) judged one of three target groups (older adults in general, physically active older adults, and socially active older adults), with regard to perceived status and competition, warmth and competence judgments, emotional and behavioral reactions. RESULTS: Results showed that being physically active was associated with higher status and competence. Physically active older adults were specifically viewed as an admired group eliciting both active (helping) and passive facilitation (associating) tendencies. CONCLUSION: Beyond the well-known health perspective related to the regular participation of older adults in physical activity, the present results open a social optimistic perspective, in which being physically active seems a promising way to challenge the widespread and resistant stereotype content of older people commonly perpetuated.

Development and validation of the Cancer Exercise Stereotypes Scale.

The objective of this study was to develop and validate a French-language questionnaire measuring stereotypes related to exercise in cancer patients: The Cancer Exercise Stereotypes Scale (CESS). Four successive steps were carried out with 806 participants. First, a preliminary version was developed on the basis of the relevant literature and qualitative interviews. A test of clarity then led to the reformulation of six of the 30 items. Second, based on the modification indices of the first confirmatory factorial analysis, 11 of the 30 initial items were deleted. A new factorial structure analysis showed a good fit and validated a 19-item instrument with five subscales. Third, the stability of the instrument was tested over time. Last, tests of construct validity were conducted to examine convergent validity and discriminant validity. The French-language CESS appears to have good psychometric qualities and can be used to test theoretical tenets and inform intervention strategies on ways to foster exercise in cancer patients.

Sociodemographic precursors of explicit and implicit attitudes towards physical activity.

OBJECTIVE: In high-income countries, people with low socio-economic status (SES) engage in less leisure-time physical activity (PA) than those with higher SES. Beyond a materialistic account of this difference, the role of motivational precursors-among which attitudes are emblematic-remains poorly understood, particularly when it comes to dissociating the automatic vs. deliberative components of attitudes. This pre-registered study aimed to examine the associations between SES (i.e. income and educational attainment) and motivational precursors of PA (i.e. explicit and implicit attitudes), and whether gender and age may moderate these relationships. METHOD: We used data from 970 adults (64% of women; mean age = 33 ± 12 years) from the Attitudes, Identities, and Individual Differences (AIID) study. RESULTS: Results of multiple linear regression analyses showed that participants with the highest level of income (>150,000$ per year) reported more positive explicit and implicit attitudes towards PA than those with lower income. Exploratory analysis further showed that women reported weaker explicit attitudes towards PA, while both explicit and implicit attitudes towards PA became weaker at age increases. In contrast, educational attainment was not significantly associated with those attitudes, and there was only mixed evidence for a moderating role of participants' gender on the pattern of associations. CONCLUSION: Our findings suggest that both the explicit and implicit attitudes towards PA may be socially patterned. Future intervention studies should examine whether these attitudinal differences could be reduced, and whether such a reduction could help buffer the unequal participation in PA behaviors across social groups.

Moving together: Increasing physical activity in older adults with an intergenerational technology-based intervention. A feasibility study.

Robust evidence supports the role of physical activity and exercise in increasing longevity, decreasing morbidity and helping older adults maintain the highest quality of life attainable. However, the majority of older adults are not sufficiently physically active and interventions are needed to change their behaviors. Familial or intergenerational contact has been positively linked to health and well-being in older adults. Therefore, this study aimed to i) establish acceptability and test the functionality and useability of a novel technology-driven intergenerational intervention targeting physical activity and age stereotypes, and ii) identify any potential issues with recruitment and retention. Four familial dyads (adult ≥ 65 and child 7-11 years) engaged with the intervention. Working collaboratively during a four-week trial, they combined daily step-counts (acquired via any activity of their choice, using PA trackers) to complete a virtual walk route using online platform World Walking. Thematic analysis of three post-intervention focus groups (one older adult; one child; one additional parental cohort) identified eight subthemes: Engagement; Provision of a Positive Experience; Participant Stimuli; Generated Outcomes; Operationality; Limitations; Mediators; Facilitators, and Perceptions. Participants enjoyed and successfully engaged with the intervention; when designing behaviour change interventions for older adults, flexibility within pre-established routines, individual choice, and avoiding rigidly imposed structures, is important. Strategies to challenge negative perceptions of older adults' engagement with technology and PA should be integrated into recruitment processes.

Development and validation of the aging stereotypes and exercise scale.

This article presents the development and validation of the aging stereotypes and exercise scale (ASES), which measures different dimensions of aging stereotypes in the exercise domain. Drawing on past research on older adults' perceived barriers to exercise, these dimensions include stereotypes about positive and negative exercise outcomes for older adults and about older adults' psychological barriers to exercise (i.e., lack of self-efficacy and motivation). Four studies involving 714 participants examined the factorial structure and invariance, temporal stability, and external validity of the scale. The results supported a 3-factor model that was invariant across age. Age differences in stereotype content appeared, with older adults holding more positive stereotypes than younger adults. Also as predicted, the more older adults endorsed negative stereotypes, the lower their physical self- worth, self-rated health, and subjective age. Last, responses to the ASES appeared to be stable over a 6-wk period.

Can stereotype threat affect motor performance in the absence of explicit monitoring processes? Evidence using a strength task.

Previous evidence shows that stereotype threat impairs complex motor skills through increased conscious monitoring of task performance. Given that one-step motor skills may not be susceptible to these processes, we examined whether performance on a simple strength task may be reduced under stereotype threat. Forty females and males performed maximum voluntary contractions under stereotypical or nullified-stereotype conditions. Results showed that the velocity of force production within the first milliseconds of the contraction decreased in females when the negative stereotype was induced, whereas maximal force did not change. In males, the stereotype induction only increased maximal force. These findings suggest that stereotype threat may impair motor skills in the absence of explicit monitoring processes, by influencing the planning stage of force production.

Validity and reliability of an app-based medical device to empower individuals in evaluating their physical capacities.

BACKGROUND: Cardiorespiratory fitness and muscle strength are valid markers of health and strong predictors of mortality and morbidity. The tests used to measure these variables require in-person visits with specialized equipment and trained personnel-leading to organizational constraints both for patients and hospitals, and making them difficult to implement at a large scale. In this context, technologies embedded in smartphones offer new opportunities to develop remote tests. OBJECTIVES: This study aimed to test the validity and reliability of MediEval, a newly developed app-based medical device that allows individuals to perform the 6-minute walk test (6MWT) and the 30-second sit-to-stand (30s-STS) test on their own using GPS signal and camera detection with a skeleton extraction algorithm. METHODS: A total of 53 healthy adults performed the two tests in three different sessions to determine the intra- and inter-day reproducibility. Test validity was assessed by comparing the results obtained from the app to gold standard measures. Pearson correlations and concordance correlation coefficients, the relative measurement error, intraclass correlation coefficients, the standard error of measure and the minimal detectable change were computed for each test.s. RESULTS: The results revealed high to excellent validity of the app in comparison to gold standards (ρ = 0.84 for the 6MWT and ρ = 0.99 for the 30s-STS test) with low relative measurement error. The mean differences between the app and the gold standard measures were 8.96m for the 6MWT and 0.28 repetition for the 30s-STS test. Both tests had good test-retest reliability (ICCs = 0.77). The minimal detectable changes were respectively 97.56 meters for the 6MWT and 7.37 repetitions for the 30s-STS test. CONCLUSION: The MediEval medical device proposes valid and reproducible measures of the 6MWT and the 30s-STS test. This device holds promise for monitoring the physical activity of large epidemiologic cohorts while refining patient experience and improving the scalability of the healthcare system. Considering minimal detectable change values, it may be important to ask participants to perform several tests and average them to improve accuracy. Future studies in clinical context are needed to evaluate the responsiveness and the smallest detectable changes of the device for specific populations with chronic diseases.

Beyond Individual Cognitions: Time for Intervention Science to Focus on Health Context and Audience.

Intervention science faces a hazardous paradox: on the one hand, vulnerable populations (eg, patients, people from low socioeconomic background, older adults) are those for whom adoption of healthy behaviors is most urgent; on the other hand, behavior change models are less predictive, and interventions less successful, in these populations. This commentary presents 4 reasons that may explain this issue: (1) research mostly focuses on what causes behavior and how to change it, at the expense of investigating among whom and under what conditions models are valid; (2) models put an undue emphasis on individual cognitions; (3) most studies are not conducted on vulnerable populations; and (4) most researchers are from high-income countries. Several avenues are proposed to address this issue: (1) providing a central place to the context and audience in health behavior change modelization, through collaborations with researchers from other disciplines and countries, and with members of the targeted audience; (2) better reporting samples' sociodemographic characteristics and increasing samples' diversity; and (3) using more rigorous and innovative designs (eg, powered randomized controlled trials, N-of-1 trials, intensive longitudinal studies). In conclusion, it becomes urgent to change the way we do research: the social utility and credibility of intervention science depend on it.

Are trait self-control and self-control resources mediators of relations between executive functions and health behaviors?

This study investigated associations between executive functions (i.e., inhibition, working memory, cognitive flexibility) and individual differences in self-control and health behaviors. We examined whether executive functions predict physical activity, sedentary activity, and healthy and unhealthy diets, and whether trait self-control and self-control resources mediate these associations. Three hundred and eighty-five participants completed a questionnaire assessing trait self-control and self-control resources, physical activity, sedentary activity, and healthy and unhealthy diets. They also performed three randomly ordered cognitive tasks, a stop-signal task (i.e., inhibition), a letter memory task (i.e., updating), and a number-letter task (i.e., switching). Structural equation modeling revealed that self-control resources predicted positively physical activity (R2 = 0.08), negatively sedentary activity (R2 = 0.03) and positively healthy diet (R2 = 10). Moreover, trait self-control predicted positively healthy diet (R2 = 0.10) and negatively unhealthy diet (R2 = 0.19). Moreover, analyses revealed that switching significantly predicted self-control resources, and highlighted three totally mediated relations between this executive function and physical activity, sedentary activity and healthy diet. However, no evidence was found supporting associations between inhibition and updating, and health behaviors, or relations mediated by self-control for these executive functions. The findings suggest the importance of trait self-control and self-control resources for health behavior adoption and pave the way for studies exploring the role of the executive functions in an affective context. Open materials [https://osf.io/hpsjw/].

Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study.

BACKGROUND: Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which could affect 200 million women (The term "woman" is used for convenience. Individuals gendered as man or as nonbinary can also suffer from this disease) worldwide. One of the most common symptoms of endometriosis is pelvic chronic pain associated with fatigue. This pain can cause psychological distress and interpersonal difficulties. As for several chronic diseases, adapted physical activity could help to manage the physical and psychological symptoms. The present study will investigate the effects of a videoconference-based adapted physical activity combined with endometriosis-based education program on quality of life, pain, fatigue, and other psychological symptoms and on physical activity. METHODS: This multicentric randomized-controlled trial will propose to 200 patients with endometriosis to be part of a trial which includes a 6-month program with 45 min to more than 120 min a week of adapted physical activity and/or 12 sessions of endometriosis-based education program. Effects of the program will be compared to a control group in which patients will be placed on a waiting list. All participants will be followed up 3 and 6 months after the intervention. None of the participants will be blind to the allocated trial arm. The primary outcome measure will be quality of life. Secondary outcomes will include endometriosis-related perceived pain, fatigue, physical activity, and also self-image, stereotypes, motivational variables, perceived support, kinesiophobia, basic psychological need related to physical activity, and physical activity barriers. General linear models and multilevel models will be performed. Predictor, moderator, and mediator variables will be investigated. DISCUSSION: This study is one of the first trials to test the effects of a combined adapted physical activity and education program for improving endometriosis symptoms and physical activity. The results will help to improve care for patients with endometriosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023.